Respiratory and Physical Therapy in Patients With Associated Pulmonary Arterial Hypertension (APAH) With Congenital Heart Defects

Influence of Respiratory and Exercise Therapy on Oxygen Uptake, Quality of Life in Patients With Severe Associated Pulmonary Arterial Hypertension (APAH) as Part of a Congenital Heart Defect With / Without Eisenmenger's Syndrome

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01397110

Enrollment

Registered

2011-07-19

Start date

2012-01-31

Completion date

2025-12-31

Last updated

2022-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eisenmenger Syndrome, Pulmonary Arterial Hypertension

Brief summary

The purpose of this study is to investigate the influence of physical training on exercise capacity, quality of life, functional class, oxygen consumption and right ventricular function in patients with severe associated pulmonary arterial hypertension (APAH) as part of a congenital heart defect with / without Eisenmenger's Syndrome

Interventions

OTHERrespiratory and exercise therapy

Conventional therapy with specific respiratory and physical therapy plus mental walking training

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* signed consent form * men and women\> 18 years \<80 years * APAH with congenital heart defects with / without Eisenmenger syndrome (WHO functional class II-IV), invasively diagnosed by right heart and left heart catheterization: mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg, with targeted PAH medication for at least two months stable before study inclusion (exception: compensated WHO class II without vasodilating drug therapy)

Exclusion criteria

* Pregnancy or lactation * Change in medication during the last 2 months * severe walking disturbance * uncertain diagnoses * No previous invasively confirmation of PH * acute diseases, infections, fever * Serious lung disease with FEV1 \<50% or TLC \<70% of target * Further

Design outcomes

Primary

Measure	Time frame
Changes in the maximum 6-minute walk distance (6MGT)	up to 15 weeks
Changes in quality of life	up to 15 weeks

Secondary

Measure	Time frame	Description
Changes in hemodynamics	up to 15 weeks	1. Changes in maximum oxygen uptake 2. Changes in exercise capacity: 6-minute walk distance, Recumbent Bike (Watts), respiratory economy (EQO2, EQCO2) 3. Improved condition(NYHA class, Borg scale) 4. Changes in Magnetic resonance tomography and echocardiographic parameters of right and left ventricle: size and pump function. 5. Change of laboratory parameters, which are markers of right heart failure as NTproBNP, interleukins

Countries

Germany

Contacts

Primary ContactEkkehard Gruenig, MD

ekkehard.gruenig@med.uni-heidelberg.de+49 6221 396 8053

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026